MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTACER BIOLOX DELTA FEMORAL BALL HEAD; BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8

Model Number	01.29.215
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The antirotational insert of the trial offset 5mm broke.Broken part retrieved and surgery completed successfully.Approximately 45 minutes of delay occurred to remove the broken part.The surgeon had to burr around the site to get access with a trauma-threaded removal tool.
Additional Manufacturer Narrative
Batch review performed on 15 september 2025: lot 2254377: (b)(4) items manufactured and released on 18-aug-2022.No anomalies found related to the problem.To date, 4 similar events have been reported on the same lot during the period of review.Visual inspection: the performed analysis confirmed that the antirotational insert of the trial offset has been disassembled from the main body during trial removal from the bone.During extraction of the system consisting of extension stem, trial offset and trial keel assembly from the bone, the elastic clipping of the threaded insert of the trial offset is unable to withstand the blows and disengages from the offset body itself.A new modification request has been opened and managed to improve the locking system between the two components of the trial offset.Additional improvement has been made on the design and production process in order to obtain the antirotational feature monoblock with the main body instead of two different components.Conclusion: the issue was likely influenced by a combination of the inherent mechanical limitations of the design version involved and the forces applied under the specific conditions of use.
Additional Manufacturer Narrative
Batch review performed on 22 december 2025 ball heads: mectacer 01.29.215 biolox delta ceramic ball head 12/14 ø 40 size xl +8 (k112115) lot 2218785: (b)(4) items manufactured and released on 02-nov-2022.Expiration date: 2027-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot 2215506: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Correction: d1, d2, d4, g4, h4.

• Brand Name: MECTACER BIOLOX DELTA FEMORAL BALL HEAD
• Common Device Name: BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 23179116
• Report Number: 3005180920-2025-00918
• Device Sequence Number: 10075068
• Product Code: LZO
• UDI-Device Identifier: 07630030809262
• UDI-Public: 07630030809262
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K112115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01.29.215
• Device Lot Number: 2218785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown